Simulation-Guided Clinical Trials: Is EU Law Ready?
Simulations do not replace human judgment: they inform it, making transparent what would otherwise remain a “black box.” EU law does not require them today; but a proportionate embrace, in the right legislative vehicle, with clear methodological standards, and without crushing noncommercial research, could make trials safer, faster, cheaper, and more reliable, without sacrificing rigor.
Nkarta Autoimmune Disease Cell Therapy’s First Human Data Show Safety, Signs of Efficacy
Nkarta will present initial clinical data for its natural killer cell therapy in two disorders, myositis and systemic sclerosis, during the American College of Rheumatology annual in Orlando this week. The biotech is part of a growing group of companies developing therapies that reset the immune system to treat autoimmune disease.
What’s Driving the Consumerization of Healthcare?
Patients increasingly expect convenient, consumer-focused healthcare experiences, panelists said at the recent MedCity INVEST Digital Health Conference.
Missing the Point: Isolation Alone Will Not Build AI Safety
Treating AI agents like contract nurses and minimizing their access to critical patient information certainly reduces potential risk. But, it also minimizes key opportunities.
Bispecific J&J Drug Wins Speedy FDA Approval for Treating Head & Neck Cancer
Accelerated FDA approval of Johnson & Johnson’s Rybrevant Faspro covers advanced cases of head and neck cancer. The bispecific antibody was initially approved for treating certain lung cancers.